Ultrasonic blade with static casing

ABSTRACT

An ultrasonic surgical device capable of cutting biological tissues such as bone and cartilage. The ultrasonic surgical device includes a static casing, which sheaths an ultrasonic horn, and a lubrication film, which separates the ultrasonic horn and the static casing. The static casing, which also incorporates a plurality of fluid channels to allow passage of fluids along its length and eventual distribution of such fluids at the cutting end and biological tissue interface, inhibits the transfer of heat generated along the ultrasonic horn. The cutting end and the static casing are separated by a flexible joint, which serves to inhibit the transfer of vibrational energy, and consequently heat, from the cutting end to the static casing. As such, the static casing remains stable and can be used both to manipulate the surgical device with greater haptic control and facilitate effective penetration of larger cross-sections of biological tissue.

CROSS-REFERENCES TO RELATED APPLICATION

This application claims the benefit of provisional patent applicationSer. No. 62/057,369, filed Sep. 30, 2014 on behalf of the presentinventors.

STATEMENT REGARDING ADDITION OF NEW MATTER

This is a substitute specification made in response to the Notice toFile Corrected Application Papers mailed on Nov. 4, 2016. Thissubstitute specification does not include new matter. Page numberrequirements (37 CFR 1.52(b)(5)) were not adhered to for thespecification as originally filed, but this substitute specification iscorrected with respect to those requirements.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGCOMPACT DISK APPENDIX

Not Applicable.

BACKGROUND OF INVENTION

1. Field of Invention

The present invention relates to the field of ultrasonic surgicaldevices capable of cutting biological tissues such as bone andcartilage.

2. Description of Related Art

Traditional surgical saws, such as oscillating saws and reciprocatingsaws, allow users to cut bones (i.e. Perform osteotomies) of relativelylarge diameters, such as the tibia and femur. These types of surgicalsaws, however, which are similar in many ways to the toothed saws usedto cut wood, metal, and plastic, have significant disadvantages withrespect to a patient's well-being. Because surgical saws utilize rapidmotion of the saw blade to cut biological tissues, such as bone andcartilage, a significant amount of heat is generated along the blade andparticularly at the blade and bone interface. This can be harmful to thepatient since prolonged exposure of bone cells to temperatures at or inexcess of 47° C. leads to necrosis of those osteocytes. Anotherdisadvantage of these oscillating and reciprocating bone saws is thatthey produce uneven cuts, preventing ideal realignment and reduction ofthe osteotomy gap, which is detrimental to efficient healing of thebone. Oscillating and, in particular, reciprocating bone saws, whichutilize a number of sharpened teeth along their cutting edges, can tearneighboring soft tissues that are inadvertently caught in the serrationsof the rapidly moving blade. Tearing of these soft tissues leads tosignificant blood loss and potential nerve damage, which undoubtedlyhampers the health of the patient.

Traditional oscillating and reciprocating bone saws have employed avariety of different measures to address these disadvantages. Withrespect to the generation of excessive heat, these surgical saws canutilize irrigation systems to flush the surgical site near the blade andbone interface. These irrigation systems can be separate, requiring anadditional device at the surgical site, or integrated. Althougheffective at flushing a surgical site of unwanted sources of addedfriction, these irrigation systems are relatively ineffective atactually cooling the blade at the blade and bone interface. For example,one design for a surgical saw that incorporates a means for irrigationcomprises a channel between otherwise parallel portions of a saw bladethrough which fluid can flow out into the surgical site (U.S. Pat. No.5,087,261). This channel, though, can be easily compacted with surgicaldebris, rendering the integrated irrigation system unusable. Inaddition, providing a channel between parallel portions of the saw bladenecessarily increases the likelihood of a wider, more uneven cut. Otherdesigns for an oscillating bone saw include outlets along the blade'sedge to facilitate irrigation along the blade and bone interface (U.S.Pat. No. 4,008,720; U.S. Pat. No. 5,122,142). However, these channelscan be similarly compacted with surgical debris, rendering them useless.More so, channels along the very blade edge result in a blade edge thatis not continuous, which reduces the cutting efficiency of the blade.Despite any potential efficacy in flushing a site of surgical debris,these systems do very little to actually cool the very blade edge,specifically at the blade and bone interface.

Just as with saws used to cut wood, metal, and plastic, a user can avoidrough or uneven cuts by using a saw blade that incorporates more teethalong the edge of the blade and/or teeth having differing angles. Whilethis can produce a relatively finer cut, the resulting cut still leavesmuch to be desired in terms of producing smooth, even bone surfaces.Cutting guides, which help to stabilize the blade and keep it on aprescribed plane, are often utilized during an osteotomy to improve theprecision of the cut. Still, the improvement is not substantial enoughto consider these measures a long-term solution with respect toproducing smooth bone cuts. In fact, adding teeth or guiding the bladeedge have little effect in preventing inadvertent tearing of neighboringsoft tissues. Although efforts are taken to protect soft tissues fromdamage and prevent significant blood loss, the inherently close confinestypical in performing any osteotomy make it extremely difficult tocompletely eliminate such damage, especially to those tissues that areunseen or positioned beneath the bone being cut. This is compounded bythe fact that the saw blades used with many oscillating andreciprocating bone saws are relatively large.

A variety of ultrasonic surgical devices are now utilized in a number ofsurgical procedures, including surgical blades that are capable ofcutting biological tissues such as bone and cartilage. These types ofsaw blades are powered by high-frequency and high-amplitude sound waves,consequent vibrational energy being concentrated at the blade's edge byway of an ultrasonic horn. Being powered by sound waves, neighboringsoft tissues are not damaged by these types of blades because theblade's edge effectively rebounds due to the elasticity of the softtissue. Thus, the significant blood loss common with use of traditionalbone saws is prevented. In addition, significantly more precise cuts arepossible using ultrasonic bone cutting devices, in part, because theblade's edge does not require serrations. Instead, a continuous andsharpened edge, similar to that of a typical scalpel, enables a user tobetter manipulate the surgical device without the deflection caused byserrations, which is common when using oscillating and reciprocatingbone saws. Although ultrasonic cutting blades are advantageous in thatthey are less likely to tear neighboring soft tissues and more likely toproduce relatively more even cuts, these types of blades still generateconsiderable amounts of heat.

As with traditional bone saws, separate or integrated irrigation systemsare often utilized in order to flush the surgical site and generallyprovide some measure of cooling effect to the blade. However, many ofthese blades suffer from the same disadvantages as traditional bone sawsthat have tried to incorporate similar measures. For example, providingopenings along the blade's edge through which fluid flows introducesvoids in the cutting edge, thereby inhibiting the cutting efficiency ofthe blade (U.S. Pat. No. 5,188,102). In addition, these fluid openingscan be readily compacted with surgical debris, rendering them uselessfor their intended function. In other blade designs, the continuity ofthe blade is maintained and a fluid outlet is positioned just before theblade's edge (U.S. Pat. No. 8,348,880). However, this fluid outletmerely irrigates the surgical site since it is positioned too far fromthe blade and bone interface to actually provide the necessary coolingeffect. Also, it irrigates only one side of the blade. Another designfor an ultrasonic cutting device, which claims to cool the blade,incorporates an irrigation output located centrally along thelongitudinal axis of the blade (U.S. Pat. No. 6,379,371). A recess inthe center of the blade tip allows fluid to flow out of this output andtoward the blade's edge, flow that is propelled by a source of pressure.However, the positioning of this irrigation output within the contour ofthe blade tip results in a bifurcation or splitting of the irrigationflow, such splitting tending to distribute fluid at an angle away fromthe blade's edge. Mentioned above, the excessive heat generated usingany cutting blade, including an ultrasonic cutting blade, is focusedmost significantly at the blade and bone interface. This example for anultrasonic blade with cooling capabilities, then, does little toactually cool the blade at the blade and bone interface, but insteadserves merely to flush debris from the surgical site. Furthermore, thisultrasonic blade is not well-suited to cutting large cross-sections ofbone and is used almost exclusively in oral or maxillofacial surgeries,which involve cutting of small bones.

Even assuming that any of the irrigation systems incorporated into thevarious bone saws provide some measure of cooling, thermal burning ofboth neighboring soft tissues and bone surfaces remains a significantproblem. Because the shaft of the blade also vibrates at a very highfrequency, considerable heat is generated along its length, too. Thevibrating shaft contacts neighboring soft tissues, potentially burningthem. With respect to an osteotomy, as the blade passes through thecross-section of bone, the freshly-cut bone surfaces remain in constantand direct contact with the rapidly vibrating shaft of the blade. As aresult, it is not uncommon to burn the bone, produce smoke and, moreimportantly, kill osteocytes. In fact, simply lengthening an ultrasonicblade to accommodate large cross-sections of bone tissue, for example,increases the surface area through which heat can transfer and, thus, isavoided by manufacturers of these types of blades. While irrigationdirected specifically toward the blade's leading edge may provide somemeasure of cooling at the blade and bone interface, irrigation alone isinsufficient in trying to avoid prolonged exposure of bone tissue, forexample, to temperatures in excess of 47° C. Therefore, there remains aneed for an ultrasonic surgical device that is capable of cutting boneswith large cross-sections, such as the femur, while maintaining aworking temperature along the entirety of the blade shaft that does notinhibit proper healing of the bone tissue.

BRIEF SUMMARY OF INVENTION

According to one embodiment, an ultrasonic surgical device capable ofcutting, ablating, abrading or otherwise transforming biological tissuescomprises a housing, at least one ultrasonic horn, a static casing, aflexible joint, and a cutting end. The housing contains components, suchas a piezoelectric transducer and transducer backing material, known inthe art to generate and propagate ultrasonic vibrations along theultrasonic horn toward the cutting end. The static casing, whichcomprises at least one sheathing slot, sheaths at least a portion of theultrasonic horn. In addition, the sheathing slot is separated from theultrasonic horn by at least one lubrication film. As a result, thestatic casing has the advantage of reducing both the generation of heatdue to movement of the ultrasonic horn and subsequent transfer of suchheat to neighboring biological tissues. In addition, the static casinghas the added benefit of providing a user with greater haptic controlduring a surgical procedure as the user can directly manipulate theultrasonic horn by way of the static casing. Not only does the staticcasing offer greater sensitivity but it enables a user to penetrate amuch larger cross-section of biological tissues without damagingadjacent tissues due to excessive heat transfer.

The static casing, according to another embodiment, further comprises aplurality of fluid channels that extend the length of the static casingand can be utilized to dispense a variety of fluids, includingtherapeutic agents and saline, to the surgical site. Fluid flowing alongthese channels is discharged at the cutting end and biological tissueinterface, where it serves, in part, to both limit heat transfer at theinterface and irrigate the surgical site. Not only does this fluid serveto cool this interface and irrigate the site but it also cools thestatic casing as it flows along these fluid channels. As a result, thesefluid channels are advantageous in further reducing the transfer of heatgenerated along the main body of the ultrasonic horn to the staticcasing, thereby reducing any likelihood of damage to adjacent tissuesthat are in contact with the static casing. This is especiallybeneficial as the cutting end penetrates deeper into large bones, forexample.

The static casing has a width and height profile similar to the cuttingend, which enables deeper penetration of the cutting end, and isseparated from the cutting end by a flexible joint. This flexible joint,preferably composed of a viscoelastic material, surrounds at least aportion of the ultrasonic horn and reduces the transfer of vibrationalenergy from the cutting end to the static casing. This separation helpsto preserve the immobility and stability of the static casing. Accordingto at least one embodiment, the flexible joint further comprises aplurality of through-ports which facilitate continuous fluid flow fromthe fluid channels, through the flexible joint, and to the cutting end.At least one embodiment comprises a cutting end having openings throughwhich fluid, that is delivered along the fluid channels of the staticcasing and through the through-ports of the flexible joint, isdischarged toward the blade and bone interface.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an exploded perspective view indicating many components of oneembodiment;

FIG. 2 is a perspective view showing an assembled example of oneembodiment;

FIG. 3 is a cross-section view of one embodiment showing a static casingsheathing an ultrasonic horn with a lubrication film separating thestatic casing from the ultrasonic horn;

FIG. 4 is a close-up perspective view indicating many details of oneembodiment of a cutting end assembly;

FIG. 5 is a perspective view of another embodiment showing a pluralityof ultrasonic horns, a plurality of sheathing slots extending through astatic casing, and a plurality of lubrication films separating theultrasonic horns from the sheathing slots;

FIG. 6 is a close-up perspective view indicating many details of anotherembodiment of a cutting end assembly;

FIG. 7 is a perspective view of another embodiment of a cutting endhaving serrations;

FIG. 8 is a close-up perspective view indicating many details of oneembodiment of a cutting end assembly that includes serrations; and

FIG. 9 is an exploded perspective view indicating many components ofanother embodiment.

REFERENCE NUMERALS FOR DRAWINGS Please Note that First Digit Indicatesthe Figure in which a Component is First Visually-Identifiable

110 Ultrasonic surgical device 112 Housing 114 Static casing 116Ultrasonic horn 118 Flexible joint 120 Cutting end 126 Sheathing slot128 Lubrication film 130 Fluid channel 132 Longitudinal edge 136 Channelinsert 138 Inlet comlector 140 Discharge orifice 142 Passage 144Attachment end 148 Top planar surface 150 Opening 152 Blade edge 156Sloped top surface 158 Interior edge 310 Static casing 312 Sheathingslot 314 Fluid channel 316 Ultrasonic horn 318 Lubrication film 320Longitudinal edge 410 Cutting end assembly 434 Through-port 454 Bottomplanar surface 460 Sloped bottom surface 462 Inlet 510 Ultrasonicsurgical device 512 Housing 514 Static casing 516 Ultrasonic horn 518Flexible joint 520 Cutting end 526 Sheathing slot 528 Lubrication film530 Fluid channel 532 Longitudinal edge 536 Channel insert 538 Inletcomlector 540 Discharge orifice 542 Passage 544 Attachment end 548 Topplanar surface 550 Opening 552 Blade edge 556 Sloped top surface 558Interior edge 610 Cutting end assembly 634 Through-port 654 Bottomplanar surface 660 Sloped bottom surface 662 Inlet 710 Ultrasonicsurgical device 712 Housing 714 Static casing 716 Ultrasonic horn 718Flexible joint 720 Cutting end 726 Sheathing slot 728 Lubrication film730 Fluid channel 732 Longitudinal edge 736 Channel insert 738 Inletcomlector 740 Discharge orifice 742 Passage 744 Attachment end 748 Topplanar surface 752 Blade edge 764 Blade teeth 810 Cutting end assembly834 Through-port 854 Bottom planar surface 862 Inlet 910 Ultrasonicsurgical device 912 Housing 914 Static casing 916 Ultrasonic horn 918Flexible joint 920 Cutting end 926 Sheathing slot 928 Lubrication film932 Longitudinal edge 942 Passage 944 Attachment end 948 Top planarsurface 952 Blade edge

DETAILED DESCRIPTION OF DRAWINGS

FIG. 1 shows an exploded perspective view of one embodiment of anultrasonic surgical device 110. The ultrasonic surgical device 110comprises a housing 112, a static casing 114, at least one ultrasonichorn 116, a flexible joint 118, and a cutting end 120. The housing 112contains components, such as a piezoelectric transducer and a transducerbacking material, known to those skilled in the art to be related to thegeneration and propagation of ultrasonic vibrations to the cutting end120. The piezoelectric transducer, which produces ultrasonic vibrations,is operatively coupled to a first end of the ultrasonic horn 116.Ultrasonic vibrations propagate along a main body of the ultrasonic horn116 toward a second end of the ultrasonic horn 116, the second end beingcoupled to the cutting end 120. The static casing 114 sheaths theultrasonic horn 116, the ultrasonic horn 116 being preferably positionedwithin a sheathing slot 126 located preferably along the centrallongitudinal axis of the static casing 114. The sheathing slot 126 andthe ultrasonic horn 116 are separated from one another by at least onelubrication film 128. The lubrication film 12R reduces transfer ofvibrational energy from the ultrasonic horn 116 and, thus, heat to thestatic casing 114. The static casing 114 and the cutting end 120 areseparated by the flexible joint 118, which reduces the transfer ofvibrational energy from the cutting end 120 to the static casing 114.

The static casing 114 comprises an attachment end 144 and an oppositeend, the attachment end 144 adapted for coupling to the housing 112. Thestatic casing 114 further comprises a plurality of fluid channels 130which extend the length of the static casing 114. These fluid channels130 allow fluid to flow through the static casing 114. A plurality oflongitudinal edges 132 further define the static casing 114, theselongitudinal edges 132 being preferably rounded or filleted. Theflexible joint 118 is characterized in part by a plurality ofthrough-ports 434 and at least one passage 142. The through-ports 434are better visualized in FIG. 4. The passage 142, which is substantiallyaligned with the sheathing slot, allows at least a portion of theultrasonic horn 116 to pass through the flexible joint 118.

Each through-port 434 comprises a channel insert 136 and an inletconnector 138. The cutting end 120 comprises a plurality of inlets 462and a plurality of discharge orifices 140. The inlets 462 are bettervisualized in FIG. 4. Each channel insert 136 communicates with one ofthe fluid channels 130 of the static casing 114. Each inlet connector138 communicates with one of the inlets 462 and each inlet 462communicates with one of the discharge orifices 140. Communicationbetween the fluid channel 130, channel insert 136, through-port 434,inlet connector 138 and inlet 462 allows fluid to flow continuously fromthe fluid channel 130, through the through-port 434, and into thecutting end 120, where the fluid is subsequently discharged at, forexample, the cutting end 120 and biological tissue interface by way ofthe discharge orifice 140. It is preferred that the flexible joint 118comprise both the channel inserts 136 and the inlet connectors 138 inorder to facilitate continuous fluid flow. However, it should be notedthat the flexible joint 118 can comprise channel inserts 136 but notinlet connectors 138, inlet connectors 138 but not channel inserts 136,or neither channel inserts 136 nor inlet connectors 138.

The cutting end 120 can be a blade tip adapted to cutting, ablating,abrading or otherwise transforming, for example, bone tissue. Thecutting end 120 comprises a top planar surface 148 and a bottom planarsurface 454, the top planar surface 148 and bottom planar surface 454defined by a plurality of openings 150. The bottom planar surface 454 isbetter visualized in FIG. 4. Each opening 150 extends through the depthof the cutting end 120 from the top planar surface 148 to the bottomplanar surface 454 and communicates with at least one of the dischargeorifices 140. Each opening 150 is substantially circular and each ischaracterized in part by a sloped top surface 156 originating from aninterior edge 158 situated approximately along the median horizontalplane of the cutting end 120. The sloped top surface 156 slopes up fromthe interior edge 158 and toward the top planar surface 148. Bettervisualized in FIG. 4, each opening 150 is further characterized by asloped bottom surface 460, which originates from the interior edge 158situated approximately along the median horizontal plane of the cuttingend 120. The sloped bottom surface 460 slopes down from the interioredge 158 and toward the bottom planar surface 454. The cutting end 120further includes at least one blade edge 152, the blade edge 152 in thisembodiment preferably being a continuous, planar arc, and sharpenedalong its entirety. It should be noted, however, that the blade edge 152can be adapted to have serrations or any other type of edge suitable forcutting, ablating, abrading or otherwise transforming, for example, bonetissue.

As shown, the longitudinal edges 132 of the static casing 114 arepreferably filleted or substantially rounded. The static casing 114 ispreferably made of a material suitable for biomedical applications, suchas titanium, stainless steel, PEEK, PE, or PTFE. Optionally, the outersurface of the static casing 114 may be coated with a lubricant, such asa solid film or a fluid film. Similarly, the cutting end 120 ispreferably made of a material suitable for biomedical applications, suchas titanium, stainless steel, PEEK, PE, or PTFE. Optionally, the cuttingend 120 may be coated with a lubricant, such as a solid film or a fluidfilm. The ultrasonic horn 116, too, is preferably made of a materialsuitable for biomedical applications, such as titanium, stainless steel,PEEK, PE, or PTFE. The lubrication film 128, which is preferably adheredto the ultrasonic horn 116, is preferably a solid film lubricant. Thelubrication film 128 may also be made of a hydrodynamic lubricant or anyother lubricant suitable for the application. Alternatively, thesheathing slot 126 may be coated with a lubrication film 128, suchlubrication film 128 being a solid film lubricant, hydrodynamiclubricant, or any other lubricant suitable for the application. Itshould be noted that both the sheathing slot 126 and the ultrasonic horn116 may be coated with the lubrication film 128. The flexible joint 118is preferably made of a viscoelastic material, such as silicone.

Ultrasonic vibrations are produced by the piezoelectric transducer andare transferred to the ultrasonic horn 116, which concentrates oramplifies these vibrations at the cutting end 120. Movement of thecutting end 120 generates heat, which can be detrimental to biologicaltissues that come in contact with the cutting end 120. Fluid, which maybe a coolant such as saline, flows through the fluid channels 130 andexits the discharge orifices 140, where it is distributed at the cuttingend 120 and biological tissue interface. Such fluid inhibits thegeneration of heat at this interface, thereby reducing the likelihood ofdamage to the tissue. In addition, fluid flowing through the fluidchannels 130 actively cools the static casing 114. Fluid flowing alongthese fluid channels 130 may also incorporate therapeutic agents, suchas bone morphogenetic protein 2, transforming growth factor B1 protein,or fibroblast growth factor 2 protein. In fact, one fluid channel can bededicated to supplying irrigation, such as saline, while another fluidchannel can be dedicated to administration of therapeutic agents.

Not only is heat generated at the cutting end 120 but it is alsogenerated along the length of the ultrasonic horn 116. The static casing114, therefore, inhibits the transfer of heat generated along theultrasonic horn 116 to neighboring tissues. In addition, the staticcasing 114 offers the user a stable means of manipulating the surgicaldevice 110 with greater sensitivity. The ultrasonic horn 116 isseparated from the sheathing slot 126 by the lubrication film 128 inorder to reduce friction caused by vibrational energy between theultrasonic horn 116 and the sheathing slot 126. The flexible joint 118separates the cutting end 120 from the static casing 114 and inhibitsthe transfer of vibrational energy from the cutting end 120 to thestatic casing 114. The flexible joint 118 and the lubrication film 128work in conjunction to inhibit transfer of vibrational energy, and thusheat, to the static casing 120. The static casing 114, havingsubstantially the same width and height profile as the cutting end 120,allows for deeper and more sensitive penetration of the surgical device110 without the attendant heat typically generated, which results fromvibrational energy and frictional forces, along the shaft of anultrasonic cutting device.

FIG. 2 is a perspective view of one embodiment in an assembled state. Anultrasonic surgical device 110 comprises a housing 112, a static casing114, a flexible joint 118, and a cutting end 120. The housing 112contains components, such as a piezoelectric transducer and a transducerbacking material, known to those skilled in the art to be related to thegeneration and propagation of ultrasonic vibrations to the cutting end120. The static casing 114 sheaths an ultrasonic horn, the ultrasonichorn 116 being preferably positioned within a sheathing slot locatedpreferably along the central longitudinal axis of the static casing 114.The ultrasonic horn and the sheathing slot are better visualized inFIG. 1. The static casing 114 comprises an attachment end 144 and anopposite end, the attachment end 144 adapted for coupling to the housing112. A plurality of longitudinal edges 132 further define the staticcasing 114, these longitudinal edges 132 being preferably rounded orfilleted. The opposite end is separated from the cutting end 120 by theflexible joint 118.

The cutting end 120 can be a blade tip adapted to cutting, ablating,abrading or otherwise transforming, for example, bone tissue. Thecutting end 120 comprises a top planar surface 148 and a bottom planarsurface 454, the top planar surface 148 and bottom planar surface 454defined by a plurality of openings 150. The bottom planar surface 454 isbetter visualized in FIG. 4. Each opening 150 extends through the depthof the cutting end 120 from the top planar surface 148 to the bottomplanar surface 454 and communicates with at least one of a plurality ofdischarge orifices 140. Each opening 150 is substantially circular andeach opening 150 is characterized in part by a sloped top surface 156originating from an interior edge 158 situated approximately along themedian horizontal plane of the cutting end 120. The sloped top surface156 slopes up from the interior edge 158 and toward the top planarsurface 148. Better visualized in FIG. 4, each opening 150 is furthercharacterized by a sloped bottom surface 460, which originates from theinterior edge 158 situated approximately along the median horizontalplane of the cutting end 120. The sloped bottom surface 460 slopes downfrom the interior edge 158 and toward the bottom planar surface 454. Thecutting end 120 further includes at least one blade edge 152, the bladeedge 152 in this embodiment preferably being a continuous, planar arc,and sharpened along its entirety. It should be noted, however, that theblade edge 152 can be adapted to have serrations or any other type ofedge suitable for cutting, ablating, abrading or otherwise transforming,for example, bone tissue.

FIG. 3 is a cross-sectional view of one embodiment, a view illustratingcomponents of a static casing 310. The static casing 310 comprises atleast one sheathing slot 312 and a plurality of fluid channels 314.There is at least one ultrasonic horn 316, the ultrasonic horn beingsheathed by the sheathing slot 312, the sheathing slot 312 being locatedpreferably along the central longitudinal axis of the static casing 310.The ultrasonic horn 316 is separated from the sheathing slot 312 by atleast one lubrication film 318. The static casing 310 is further definedby a plurality of longitudinal edges 320, the longitudinal edges 320being preferably filleted or rounded.

The lubrication film 318, which is preferably a solid film lubricant,can coat the outer surface of the ultrasonic horn 316, the inner surfaceof the sheathing slot 312, or both the outer surface of the ultrasonichorn 316 and the inner surface of the sheathing slot 312. Thelubrication film 318 may also be a hydrodynamic lubricant or any otherlubricant suitable for the application. The lubrication film 318inhibits the transfer of vibrational energy, and thus heat, from theultrasonic horn 316 to the static casing 310. The fluid channels 314allow the flow of various types of fluid, including coolants,therapeutic agents, and osteoinductive agents, through the static casing310.

FIG. 4 is a close-up and exploded perspective view of one embodiment ofa cutting end assembly 410. The cutting end assembly 410 comprises acutting end 120, a flexible joint 118, and an opposite end of a staticcasing 114. An ultrasonic horn 116 comprises a first end and a secondend, the second end coupled to the cutting end 120. The static casing114 is better visualized in FIG. 1. At least a portion of the ultrasonichorn 116 is surrounded by the flexible joint 118, the flexible joint 118separating the cutting end 120 from the opposite end of the staticcasing 114. The cutting end 120 comprises a plurality of inlets 462 anda plurality of discharge orifices 140. Each inlet 462 communicates withat least one of the discharge orifices 140. The cutting end 120 furthercomprises a blade edge 152, the blade edge 152 illustrated being acontinuous arc that is sharpened along its entirety. The cutting end 120is characterized in part by a top planar surface 148, the top planarsurface 148 being defined by a plurality of openings 150.

Each opening 150 communicates with at least one of the dischargeorifices 140. Each opening 150 extends the depth of the cutting end 120from the top planar surface 148 to a bottom planar surface 454 of thecutting end 120. Each opening 150 is characterized in part by both asloped top surface 156 and a sloped bottom surface 460. Both the slopedtop surface 156 and the sloped bottom surface 460 originate from aninterior edge 158, the interior edge 158 being positioned approximatelyalong the median horizontal plane of the cutting end 120. The interioredge 158 extends substantially around the circumference of the opening150. The sloped top surface 156, originating from the interior edge 158,extends substantially around the circumference of the opening 150 andslopes away from the interior edge 158 toward the top planar surface148. The sloped bottom surface 460, originating from the interior edge158, extends substantially around the circumference of the opening 150and slopes away from the interior edge 158 toward the bottom planarsurface 454.

The flexible joint 118 comprises a plurality of through-ports 434, aplurality of channel inserts 136, and a plurality of inlet connectors138. The flexible joint 118 further comprises a passage 142, the passage142 being substantially aligned with a sheathing slot 126 defining thestatic casing 114. The sheathing slot 126 and static casing 114 arebetter visualized in FIG. 1. At least a portion of the ultrasonic horn116 passes through the passage 142. Each channel insert 136 communicatesat one end with at least one of a plurality of fluid channels 130defining the static casing 114. Each channel insert 136 communicates atan opposite end with one of the through-ports 434. Each inlet connector138 communicates at one end with one of the through-ports 434 andcommunicates at an opposite end with one of the inlets 462.Communication between the fluid channels 130, channel inserts 136,through-ports 434, inlet connectors 138, inlets 462, and dischargeorifices 140 allows fluid to flow continuously from its source towardthe blade edge 152. In addition to facilitating the continuous flow offluid from the fluid channels 130 to the inlets 462, the flexible joint118 also reduces the transfer of vibrational energy from the cutting end120 to the static casing 114.

FIG. 5 is an exploded perspective view of another embodiment. Anultrasonic surgical device 510 comprises a housing 512, a static casing514, a plurality of ultrasonic horns 516, a flexible joint 518, and acutting end 520. The housing 512 contains components, such as apiezoelectric transducer and a transducer backing material, known tothose skilled in the art to be related to the generation and propagationof ultrasonic vibrations to the cutting end 520. The piezoelectrictransducer, which produces ultrasonic vibrations, is operatively coupledto the first end of each ultrasonic horn 516. Vibrations propagate alongthe main body of each ultrasonic horn 516 toward the second end of eachultrasonic horn 516, the second end of each ultrasonic horn beingcoupled to the cutting end 520. The static casing 514 sheaths theplurality of ultrasonic horns 516, each ultrasonic horn 516 beingpreferably positioned within a sheathing slot 526 located approximatelyalong the central longitudinal axis of the static casing 514. It shouldbe noted that the plurality of ultrasonic horns 516 may be sheathedindividually within a sheathing slot 526 or the plurality of ultrasonichorns 516 may be sheathed collectively within a sheathing slot 526.Alternatively, groupings of the plurality of ultrasonic horns 516 may besheathed within separate sheathing slots 526 so that, for example, someultrasonic horns 516 are sheathed within one sheathing slot 526 whileother ultrasonic horns 516 are sheathed within an adjacent sheathingslot 526. Each sheathing slot 526 and each ultrasonic horn 516 areseparated from one another by at least one lubrication film 528. Thelubrication film 528 reduces transfer of vibrational energy from theultrasonic horn 516 and, thus, heat to the static casing 514. The staticcasing 514 and the cutting end 520 are separated by the flexible joint518, which reduces the transfer of vibrational energy from the cuttingend 520 to the static casing 514.

The static casing 514 comprises an attachment end 544 and an oppositeend, the attachment end 544 adapted for coupling to the housing 512. Thestatic casing 514 further comprises a plurality of fluid channels 530which extend the length of the static casing 514. A plurality oflongitudinal edges 532 further define the static casing 514, theselongitudinal edges 532 being preferably rounded or filleted.

The flexible joint 518 is characterized in part by a plurality ofchannel inserts 536, a plurality of inlet connectors 538, and at leastone passage 542. The passage 542 is substantially aligned with thesheathing slot 526 and allows at least a portion of at least one of theultrasonic horns 516 to pass through the flexible joint 518. Bettervisualized in FIG. 6, the flexible joint further comprises a pluralityof through-ports 634. Each channel insert 536 communicates with thefluid channel 530 of the static casing 514, allowing fluid to flowcontinuously from the fluid channel 530 through the through-port 634.

The cutting end 520 includes a plurality of inlets 662, a plurality ofdischarge orifices 540, and a plurality of openings 550. Each inletconnector 538 communicates with one of the inlets 662, each inlet 662communicating with at least one of the discharge orifices 540. Eachdischarge orifice 540 communicates with at least one opening 550.Communication between the fluid channel 530, the channel insert 536, thethrough-port 634, the inlet connector 538, the inlet 662 and thedischarge orifice 540 facilitates the continuous flow of fluid throughthe static casing 514, flexible joint 518, and to the cutting end 520.It is preferred that the flexible joint comprise both the channelinserts and the inlet connectors in order to facilitate continuous fluidflow. However, it should be noted that the flexible joint can comprisechannel inserts but not inlet connectors, inlet connectors but notchannel inserts, or neither channel inserts nor inlet connectors.

The cutting end 520 can be a blade tip adapted to cutting, ablating,abrading or otherwise transforming, for example, bone tissue. Thecutting end 520 comprises a top planar surface 548 and a bottom planarsurface 654. The bottom planar surface 654 is better visualized in FIG.6. The cutting end 520 further includes at least one blade edge 552, theblade edge 552 preferably being a continuous, planar arc, and sharpenedalong its entirety. It should be noted, however, that the blade edge 552can be adapted to have serrations or any other type of edge suitable forcutting, ablating, or otherwise transforming, for example, bone tissue.Each opening 550 extends through the depth of the cutting end 520 fromthe top planar surface 548 to the bottom planar surface 654. Eachopening 550 is substantially circular and each is characterized in partby a sloped top surface 556 originating from an interior edge 558situated approximately along the median horizontal plane of the cuttingend 520. The sloped top surface 556 slopes up from the interior edge 558and toward the top planar surface 548. Better visualized in FIG. 6, eachopening 550 is further characterized by a sloped bottom surface 660,which originates from the interior edge 558 situated approximately alongthe median horizontal plane of the cutting end 520. The sloped bottomsurface 660 slopes down from the interior edge 558 and toward the bottomplanar surface 654.

FIG. 6 is a close-up and exploded perspective view of one embodiment ofa cutting end assembly 610. A plurality of ultrasonic horns 516 areattached to the cutting end 520. The cutting end 520 comprises aplurality of inlets 662 and a plurality of discharge orifices 540, eachinlet 662 communicating with at least one of the discharge orifices 540.The cutting end 520 further comprises a blade edge 552, the blade edge552 illustrated having a continuous arc that is sharpened along itsentirety. The cutting end 520 is characterized in part by a top planarsurface 548, the top planar surface 548 being defined by a plurality ofopenings 550. Each opening 550 communicates with at least one of thedischarge orifices 540. A flexible joint 518 comprises a plurality ofthrough-ports 634, a plurality of channel inserts 536, and a pluralityof inlet connectors 538. The flexible joint 518 further comprises atleast one passage 542, the passage being substantially aligned with asheathing slot 526 defining a static casing 514. The sheathing slot 526and static casing 514 are better visualized in FIG. 4. At least aportion of at least one of the ultrasonic horns 516 passes through thepassage 542.

Each opening 550 extends the depth of the cutting end 520 from the topplanar surface 548 to a bottom planar surface 654 of the cutting end520. Each opening 550 is characterized in part by both a sloped topsurface 556 and a sloped bottom surface 660. Both the sloped top surface556 and the sloped bottom surface 660 originate from an interior edge558, the interior edge 558 being positioned approximately along themedian horizontal plane of the blade tip 546. The interior edge 558extends substantially around the circumference of the opening 550. Thesloped top surface 556, originating from the interior edge 558, extendssubstantially around the circumference of the opening 550 and slopesaway from the interior edge 558 toward the top planar surface 548. Thesloped bottom surface 660, originating from the interior edge 558,extends substantially around the circumference of the opening 550 andslopes away from the interior edge 558 toward the bottom planar surface654.

Each channel insert 536 communicates at one end with one of the fluidchannels 530 defining a static casing 514. The static casing 514comprising the fluid channels 530 is better visualized in FIG. 5. Eachchannel insert 536 communicates at an opposite end with one of thethrough-ports 634. Each inlet connector 538 communicates at one end withone of the through-ports 634 and communicates at an opposite end withone of the inlets 562. Communication between the fluid channels 530,channel inserts 536, through-ports 634, inlet connectors 538, inlets662, and discharge orifices 540 allows fluid to flow continuously fromits source toward the blade edge 552. In addition to facilitating thecontinuous flow of fluid from the fluid channels 530 to the inlets 662,the flexible joint 518 also reduces the transfer of vibrational energyfrom the cutting end 520 to the static casing 514.

FIG. 7 is an exploded perspective view of another embodiment. Anultrasonic surgical device 710 comprises a housing 712, a static casing714, an ultrasonic horn 716, a flexible joint 718, and a cutting end720. The housing 712 contains components, such as a piezoelectrictransducer and a transducer backing material, known to those skilled inthe art to be related to the generation and propagation of ultrasonicvibrations to the cutting end 720. The piezoelectric transducer, whichproduces ultrasonic vibrations, is operatively coupled to the first endof the ultrasonic horn 716. Vibrations propagate along the main body ofthe ultrasonic horn 716 toward the second end of each ultrasonic horn716, the second end being coupled to the cutting end 720. The staticcasing 714 sheaths the ultrasonic horn 716, the ultrasonic horn 716being preferably positioned within a sheathing slot 726 locatedapproximately along the central longitudinal axis of the static casing714. The sheathing slot 726 and the ultrasonic horn 716 are separatedfrom one another by at least one lubrication film 728. The lubricationfilm 728 reduces transfer of vibrational energy from the ultrasonic horn716 and, thus, heat to the static casing 714. The static casing 714 andthe cutting end 720 are separated by the flexible joint 718, whichreduces the transfer of vibrational energy from the cutting end 720 tothe static casing 714.

The static casing 714 comprises an attachment end 744 and an oppositeend, the attachment end 744 adapted for coupling to the housing 712. Thestatic casing 714 further comprises a plurality of fluid channels 730which extend the length of the static casing 714. A plurality oflongitudinal edges 732 further define the static casing 714, theselongitudinal edges 732 being preferably rounded or filleted. Theflexible joint 718 is characterized in part by a plurality of channelinserts 736, a plurality of through-ports 834, a plurality of inletconnectors 738, and at least one passage 742. The passage 742, which issubstantially aligned with the sheathing slot 726, allows at least aportion of the ultrasonic horn 716 to pass through the flexible joint718. Each channel insert 736 communicates with the fluid channel 730 ofthe static casing 714, allowing fluid to flow continuously from thefluid channel 730 through the through-port 834. The cutting end 720includes a plurality of inlets 862 and a plurality of discharge orifices740. The through-ports 834 and inlets 862 are better visualized in FIG.8. Each inlet connector 738 communicates with one of the inlets 862 andeach inlet 862 communicates with at least one of the discharge orifices740. Communication between the fluid channel 730, the channel insert736, the through-port 834, the inlet connector 738, the inlet 862 andthe discharge orifice 740 facilitates the continuous flow of fluidthrough the static casing 714, flexible joint 718, and to the cuttingend 720. It is preferred that the flexible joint 718 comprise both thechannel inserts 736 and the inlet connectors 738 in order to facilitatecontinuous fluid flow. However, it should be noted that the flexiblejoint 718 can comprise channel inserts 736 but not inlet connectors 738,inlet connectors 738 but not channel inserts 736, or neither channelinserts 736 nor inlet connectors 738.

The cutting end 720 can be a blade tip adapted to cutting, ablating,abrading or otherwise transforming, for example, bone tissue. Thecutting end 720 comprises a top planar surface 748 and a bottom planarsurface 854. The bottom planar surface 854 is better visualized in FIG.8. The cutting end 720 further includes at least one blade edge 752, theblade edge 752 in this embodiment preferably having serrations along atleast a portion of the blade edge 752. These serrations comprise aplurality of blade teeth 764. It should be noted, however, that theblade edge 752 can be adapted to have any other type of edge suitablefor cutting, ablating, or otherwise transforming, for example, bonetissue.

FIG. 8 is a close-up and exploded perspective view of one embodiment ofa cutting end assembly 810. An ultrasonic horn 716 is attached to thecutting end 720. The cutting end 720 comprises a plurality of inlets 862and a plurality of discharge orifices 740, each inlet 862 communicatingwith at least one of the discharge orifices 740. The cutting end 720further comprises a blade edge 752, the blade edge 752 illustratedhaving serrations along at least a portion of the blade edge 752. Thecutting end 720 is characterized in part by a top planar surface 748 anda bottom planar surface 854. A flexible joint 718 comprises a pluralityof through-ports 834, a plurality of channel inserts 736, and aplurality of inlet connectors 738. The flexible joint 718 furthercomprises a passage 742, the passage 742 being substantially alignedwith a sheathing slot 726 defining a static casing 714. The sheathingslot 726 and static casing 714 are better visualized in FIG. 7. At leasta portion of the ultrasonic horn 716 passes through the passage 742.

Each channel insert 736 communicates at one end with one of the fluidchannels 730 defining a static casing 714. Each channel insert 736communicates at an opposite end with one of the through-ports 834. Eachinlet connector 738 communicates at one end with one of thethrough-ports 834 and communicates at an opposite end with one of theinlets 862. Communication between the fluid channels 730, channelinserts 736, through-ports 834, inlet connectors 738, inlets 862, anddischarge orifices 740 allows fluid to flow continuously from its sourcetoward the blade edge 752. In addition to facilitating the continuousflow of fluid from the fluid channels 730 to the inlets 862, theflexible joint 718 also reduces the transfer of vibrational energy fromcutting end 720 to the static casing 714.

FIG. 9 is an exploded perspective view of another embodiment for anultrasonic surgical device. The ultrasonic surgical device 910 comprisesa housing 912, a static casing 914, an ultrasonic horn 916, a flexiblejoint 918, and a cutting end 920. The housing 912 contains components,such as a piezoelectric transducer and a transducer backing material,known to those skilled in the art to be related to the generation andpropagation of ultrasonic vibrations to the cutting end 920. Thepiezoelectric transducer, which produces ultrasonic vibrations, isoperatively coupled to the first end of the ultrasonic horn 916.Vibrations propagate along the main body of the ultrasonic horn 916toward the second end of each ultrasonic horn 916, the second end beingcoupled to the cutting end 920. The static casing 914 sheaths theultrasonic horn 916, the ultrasonic horn 916 being preferably positionedwithin a sheathing slot 926 located approximately along the centrallongitudinal axis of the static casing 914. The sheathing slot 926 andthe ultrasonic horn 916 are separated from one another by at least onelubrication film 928. The lubrication film 928 reduces transfer ofvibrational energy from the ultrasonic horn 916 and, thus, heat to thestatic casing 914. The static casing 914 and the cutting end 920 areseparated by the flexible joint 918, which reduces the transfer ofvibrational energy from the cutting end 920 to the static casing 914.

The static casing 914 comprises an attachment end 944 and an oppositeend, the attachment end 944 adapted for coupling to the housing 912. Aplurality of longitudinal edges 932 further define the static casing914, these longitudinal edges 932 being preferably rounded or filleted.The flexible joint 918 is characterized in part by at least one passage942. The passage 942, which is substantially aligned with the sheathingslot 926, allows at least a portion of the ultrasonic horn 916 to passthrough the flexible joint 918. The cutting end 920 can be a blade tipadapted to cutting, ablating, or otherwise transforming, for example,bone tissue. The cutting end 920 comprises a top planar surface 948 anda bottom planar surface. The cutting end 920 further includes at leastone blade edge 952.

While specific embodiments of the present invention and applications ofthe invention have been described herein, it will be apparent to thoseof ordinary skill in the art that many variations on the embodiments andapplications described herein are possible without departing from thescope of the invention described and claimed herein. It should beunderstood that while certain embodiments of the invention have beenshown and described, the invention is not to be limited to the specificembodiments described and illustrated.

What is claimed is:
 1. An ultrasonic bone cutting device, comprising: ahousing, said housing containing a source of ultrasonic vibrations; anultrasonic horn, said ultrasonic horn having a first end, an elongatedmain body, and a second end, said first end coupled to said source ofultrasonic vibrations, said second end coupled to a cutting end, saidcutting end comprising top planar surface and opposing bottom planarsurface, a distal continuous blade edge without interrupting openingsconnecting the top planar surface to the bottom planar surface, aplurality of spaced apart through discharge orifices extending through adepth of the cutting end through the top and bottom planar surfaces andspaced apart from the continuous blade edge, and a proximal edgeconnecting the top planar surface to the bottom planar surface andincluding a plurality of spaced apart inlets in fluid communication withthe through discharge orifices; a static casing formed from a rigidbiocompatible material, said static casing having an attachment end, anopposite end, and a sheathing slot, said static casing defining aplurality of spaced apart fluid channels, said fluid channels extendinga length of said static casing, said attachment end configured to becoupled to said housing, said sheathing slot extending the length ofsaid static casing, said sheathing slot sheathing a length of saidelongated main body; said static casing having a height and a widthprofile equal to a height and a width profile of said cutting end; asolid lubrication film adhered to at least one of an external surface ofthe elongated main body and an internal surface of the sheathing slot,said solid lubrication film separating said sheathing slot from saidelongated main body; a flexible joint formed from a viscoelasticmaterial, said flexible joint positioned between said opposite end ofsaid static casing and said proximal edge of said cutting end, saidflexible joint having a height and a width profile equal to the heightand the width profile of said cutting end, said flexible joint having aproximal end and a distal end, said proximal end defining a plurality ofspaced apart channel inserts and said distal end defining a plurality ofspaced apart inlet connectors in fluid communication with said channelinserts, such that a through-port extends through each of the channelinserts and the corresponding inlet connector, and said flexible jointdefining a passage extending therethrough, said through-ports are influid communication with said spaced apart fluid channels and saidspaced apart inlets, said passage substantially aligned with saidsheathing slot, a portion of said elongated main body passing throughsaid passage; and whereby fluid from at least one reservoir flowsthrough said fluid channels, through said through-ports, and out of saidthrough discharge orifices, said fluid cools said ultrasonic horn, saidstatic casing, said flexible joint, and said cutting end, saidlubrication film reduces generation of heat between said sheathing slotand said elongated main body, said static casing configured to reducestransfer of heat generated by the ultrasonic vibrations along the lengthof said elongated main body to neighboring biological tissues, saidflexible joint reduces transfer of the ultrasonic vibrations from saidcutting end to said static casing, the equal height and width profilesof said static casing, said flexible joint, and said cutting endconfigured to facilitate effective penetration into and cutting of largecross-sections of biological tissue.
 2. The ultrasonic bone cuttingdevice of claim 1, wherein said solid lubrication film coats a portionof at least one of said main body and said sheathing slot.
 3. Theultrasonic bone cutting device of claim 1, wherein said blade edge isconfigured for ablating.
 4. The ultrasonic bone cutting device of claim1, wherein said blade edge is configured for abrading.
 5. The ultrasonicbone cutting device of claim 1, wherein a portion of an outer surface ofat least one of said static casing and said cutting end is coated with alubricant.
 6. The ultrasonic bone cutting device of claim 1, whereinsaid fluid channels are individually operable such that each of saidfluid channels configured to deliver at least one of separate fluids,separate fluid volumes, or separate fluid pressures to the cutting end.